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Abbott's HIV Test Provides Earlier Detection

Silk Shows Promise for Implantable Biochips

Silk from silkworms (above) could serve as the foundation of future biochips for inexpensive and fast test results.

When many people think of the properties of silk, smoothness comes to mind, thanks to the common phrase 'silky smooth.' But a rash of recent medtech research projects are trying to capitalize on silk's natural strength and biocompatibility rather than its texture. The latest in a line of silk-related medical technology breakthroughs centers on the use of silk as the basis for a biochip that promotes point-of-care diagnostics.

Working with researchers at Tufts University (Medford, MA), Peter Domachuk, a physicist at The University of Sydney (Australia), has investigated silk and fibroin, the protein responsible for the material's strength. The group determined that by purifying fibroin, it forms a clear material on which minuscule drops of thousands of biochemical compounds can be displayed in various patterns.

"The particularly interesting thing about silk is that the biochemical compounds it holds retain their activity," Domachuk says. "This biochemical activity enables extra sensitivity for monitoring and detecting medical conditions. And fibroin is transparent and can be formed into structures to control light, which can be then used as a sensitive probe for improved medical testing." Silk's surface can also be etched with nanometer precision while embedded proteins function normally, Domachuk told the Sydney Morning Herald.

Medical testing can be performed, Domachuk speculates, by using the silk to create tiny testing platforms in the form of implantable biochips. He estimated that a prototype could be achieved in roughly four years.

Bayer MaterialScience Expands Medical Coatings Development Centre

Bayer MaterialScience LLC (Pittsburgh) announced at the MD&M East trade show in New York that it has expanded its Medical Coatings Development Centre in Sheffield, UK. Acquired earlier this year when Bayer purchased Polybiomed, the center offers expanded capacity for conducting feasibility studies and customer development support.

The recent introduction of Baymedix C in Europe and the United States prompted a flurry of customer requests, remarks Paul Nowatzki, responsible for the company business development, medical coatings. "Before, we were only able to send samples and explain the Baymedix CH hydrophilic polyurethane coating technology to customers." With the upgraded Sheffield facility, which is solely dedicated to Baymedix C coatings for medical devices, the company can now apply its own capabilities and know-how to help customers take the first step toward evaluation, Nowatzki adds.

As part of a move to increase staffing at the facility, the company has added a full-time process engineer, who will help to scale up manufacturing processes using Baymedix coating products. The scale-up process is important to customers, notes the company, and implementation support is deemed a crucial element of success.

Bayer MaterialScience has also made a capital investment, installing new dip-coating equipment that allows the processing of samples measuring up to 140 cm in length. This technology upgrade will enable the company to apply coatings to full-length cardiovascular catheters.

At MDM East, the supplier also announced that it has added a dry-out resistant lubricious coating to its Baymedix portfolio. Once wetted, Baymedix CL 300 can be exposed to air for as long as 10 minutes before it begins to lose lubricity. The new coating is an option for challenging acidic applications with a pH of less than 5 or for devices that are exposed to air for long periods of time, Nowatzki says.

Covidien to Acquire Somanetics Corp.

Somanetics makes cerebal and somatic oximetry products, including the In-Vivo Optical Spectroscopy. Covidien says that the acquisition of the manufacturer will enable it to "add another market-leading technology to its portfolio."

The transaction is expected to be completed by July 31, 2010.

This Week In Brief: June 15, 2010

Orthofix International has selected Omni Components Corp. (Hudson, NH) as its 2009 Supplier of the Year for spinal implant products. The supplier is an ISO 9001- and ISO 13485-certified provider of precision machining services and engineered solutions using CNC Swiss, milling and turning, vertical milling, and EDM technologies. 

Agion Technologies (Wakefield, MA), a provider of customized antimicrobial products based on ionized silver, has announced the launch of the Medical Device Market Acceleration Program (MedMAP), which offers medical device manufacturers a service designed to accelerate the development and regulatory clearance of 510 (k) and CE devices that feature the company's antimicrobial protection. MedMAP helps to efficiently move products from concept to development, through regulatory approvals to commercialization, according to the company.

Dolomite (Charlestown, MA) has unveiled a redesigned Web site, which it claims boasts a vibrant new look, clearer design, and easier navigation. Features of the new site include news updates, download sections, a search function, and central navigation across the site.

Ametek Inc. (Paoli, PA) says that it has acquired privately held Technical Services for Electronics (TSE; Arlington, MN) for an undisclosed amount. With reported annual sales of $50 million, TSE makes engineered interconnect products for ultrasound, neurostimulation, patient-monitoring, and other medical applications. Ametek, a manufacturer of electric motors and battery chargers, bought TSE from Pfingsten Partners LLC, a private equity firm in Chicago. TSE will become part of Ametek's electromechanical group, which supplies electrical interconnects, specialty metals, technical motors, floor-care motors, and specialty motors.

Robots: Not Always A Surgeon's Best Friend

The researchers, who presented their work in the journal Fertility and Sterility, had expected robot-assisted surgeries to go more smoothly than those without the help. In an analysis of 78 minor surgeries (39 with a robot, 39 without) performed on women afflicted with endometriosis, there were no complications and no different in blood loss in either group. However, robotic surgeries took 40 minutes longer, clocking in with an average time of 3 hours and 11 minutes. Experts say that longer surgeries can result in a more fatigued surgeon, and, as a result, more chances for something to go wrong.

"We were surprised that (surgery with the robot) did not have better outcomes than (the surgeon alone), as we have always believed if you can see more and see better you can do more and do better," the authors write.

Nonetheless, the study authors suggest that a robot may be more helpful for the more complicated procedures used to treat severe endometriosis, which might require open surgery.

DimcoGray Forms DG Medical

DimcoGray (Centerville, OH) specializes in the manufacture of commercial and industrial knobs and handles, but now the company is extending its reach into the medical device manufacturing realm. With the launching of DG Medical (Centerville, OH), the company is increasing its ability to meet the contract thermoplastic molding needs of medical device OEMs. The new venture rests on DimcoGray's 86 years of molding experience and more than 30 years of expertise in the area of thermoplastic molding for the medical industry.

Recently, DG Medical received ISO 13485:2003 certification, confirming that the company implements the quality management systems, management principles, resources, production processes, and measurement techniques needed to meet customer and regulatory requirements applicable to medical devices and related services. The certification also confirms that DG Medical utilizes strict process validation and controls to provide traceability throughout the production process.

Along with its commitment to meeting medical industry standards requirements, DG Medical is dedicated to serving medical OEMs through ongoing capital investments in state-of-the-art equipment and cleanroom environments, several of which the company says it will complete later this summer. "We are committed to making significant capital investments that will quickly expand our product and service offerings to the medical industry," says Mike Sieron, president and CEO of DG Medical.

In addition to thermoplastic molding, the new company offers OEMs a variety of other capabilities, including thermoset molding, ultrasonic and resistance welding, insert molding, overmolding, assembly, bar coding, and prototyping services.

Mobile Vital Signs Monitor Benefits from Collaboration

Responding to the growing interest in remote patient-monitoring applications, Sotera Wireless (San Diego) has developed the ViSi Mobile wireless platform for continuous vital signs monitoring. Body-worn sensors comprise a wireless device that can be strapped to a patient's arm for the recording of such data as blood pressure and heart rate. A monitoring device, in turn, provides remote clinicians with access to the data being recorded in order to allow for remote patient monitoring of vital signs.

Because it would ultimately be used by patients, not clinicians, and had unique requirements, the design and development of the product presented some challenges. "When Sotera Wireless approached us with this medical device design concept, it wanted the look and feel of a small, user-friendly consumer product, but had a number of specific demands. The device had to be chemical-resistant, durable, easy-to-clean, and submersible under water," recalls Michael Swartz, growth strategist at product design company DD Studio (Carlsbad, CA). "We weren't sure the design was possible."

Helping to make the design possible, for one, was the use of Tritan copolyester MX711. Manufactured by Eastman Chemical Co. (Kingsport, TN), Tritan was employed in the product's lens, housing, printed circuit board assembly, and connectors. Offering chemical resistance and durability, the material also enabled fit and press assembly of the device along with the joining of parts without the use of chemicals, adhesives, or mechanical fasteners, according to the company.

To accommodate all of the requirements stated by Sotera, however, the product needed a material capable of withstanding water submersion for 60 minutes at a depth of 1 m. DD Studios ultimately selected the GLS Versaflex OM 3060 thermoplastic elastomer, supplied by PolyOne (Cleveland), to seal the housing and protect internal electronics. The material also adhered firmly to the Tritan substrate.

Upon completing materials selection, DD Studios approached Phillips Plastics Corp. (Hudson, WI) to evaluate design for manufacturability and develop prototype tooling. The resulting product met Sotera's initial design requirements, enabling the creation of a novel remote patient-monitoring product.

Genetic Tests Count as Devices, says FDA

Director of the Office of In Vitro Diagnostic Device Evaluation, CDRH, Alberto Gutierrez said the tests constitute medical devices because they are "intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment or prevention of disease" or are "intended to affect the structure or function of the body."

In a statement, 23andMe said, "We disagree with the FDA's conclusion. ... We carefully explain to our customers that the data we provide is informational and educational." If customers want to use the information for medical decision-making, the statement says, 23andMe cautions that they consult with a doctor.

Navigenics took a similar stance, saying, "We believe our services comply with all existing federal and state regulations, and look forward to continuing our dialogue with the FDA to ensure transparency and the optimal use of genetic information as it applies to personalized medicine.

Some of the tests cited by the FDA have been sold for more than two years, and Gutierrez's letters say agency officials met with company representatives last summer. When asked why the FDA only now sent the letters, Gutierrez told the press, "If you look at the claims, they have continued to change." Although they might have started out offering tests to determine paternity or ancestry, "they began slowly making claims that we would consider high-risk, more medical-device-type claims."

According to Caroline Wright, head of science at the PHG Foundation, classifying these kits as devices may not be enough. "One of the biggest issues is that, while classifying DTC genetics tests as devices is certainly appropriate for assessing their analytical validity and direct safety, it does not and cannot provide an assessment of the service. Unlike testing kits, for which the devices legislation is designed, genome scans include an additional element of interpretation provided by the companies. This aspect of the testing service is extremely difficult to regulate, not least because the interpretation and performance of the test vary substantially between different contexts. Hence standard medical testing has traditionally been overseen by professional medical bodies. Simply trying to classify the complete genomic testing service as “a device” is entirely inadequate and will not address the difficult issues at hand."

However, she notes that the technology is not yet accurate enough to be used as a medical tool, and therefore suggests that "the best way to deal with this issue may be to ensure transparency and the provision of accurate information to consumers, to allow them to make informed decisions and to minimize the opportunities for harm."

Pharmalive.com Releases Second Annual Top 100 Medical Device Companies Special Report

Breakthrough advancements in medical devices and convergent technologies for the development of next-generation products have improved patient monitoring, safety and outcomes, reduced recovery time, and prevented costly complications.
 
Many U.S.-based device companies are developing partnerships on a global scale to pursue innovation and implement strategies that will allow them to expand into emerging markets. Corporate managers believe that this strategy will offset the impact of diminishing VC investment due to almost-certain changes regarding the U.S. approval pathway for medical devices and the proposed innovation tax that skeptics fear may stifle innovation, decrease job opportunities, and limit solutions available to patients.
 
Although U.S. companies make up more than half of the listing of the top 100 medical device companies, the proliferation of international giants shows that the industry is generating more and more profits from global outreach efforts, particularly in China, Japan, and Europe.
 
Despite all of the acquisitions occurring in the medical device sector as well as the new crop of small start-up companies, almost all of the top 100 medical device companies based on 2008 revenue retained the same status based on 2009 sales. The Johnson & Johnson family of businesses remains the world’s largest and most diverse medical device and diagnostic company.
 
Through acquisitions, Siemens Healthcare is the first integrated healthcare company combining imaging and lab diagnostics, therapy, and healthcare IT solutions supplemented by consulting and support services. Siemens delivers solutions across the entire continuum of care – from prevention and early detection, to diagnosis, therapy, and care. In the company’s fiscal year ended Sept. 30, 2009, Siemens Healthcare generated revenue of 11.95 billion euros and profit of roughly 1.45 billion euros.
 
New product innovation usually plays the most prominent role in determining company success and sustainability year after year.
 
“The top 100 companies generated $277.18 billion in 2009 medical technology revenue (excluding certain companies’ other industry sales), an increase compared with the 2008 figure of $271.97 billion,” says Andrew Humphreys, editor in chief of Canon Data Products Group. “The United States leads the way with 59 out of the top 100 device companies, followed by Europe with 25 and the Asia-Pacific region with 16.”
 
Data featured in this report include:
  • Company overview
  • Six fiscal years of financial data
  • Rankings by revenue
  • Leadership personnel
  • M&A activity
  • Key products
 
This PharmaLive Special Report is available at www.PharmaLive.com/specialreports.
 
For more information, contact Sandra Baker at 215-944-9836 or [email protected].
 
About Canon Data Products Group
Canon Data Products Group, a division of Canon Communications LLC, publishes PharmaLive and Appliance Special Reports, which provide financial, company, and product statistical data and qualitative analysis for the global pharmaceutical, biotechnology, medical device, and appliance industries; maintains eKnowledgeBase and MDRWeb, comprehensive market intelligence tools serving the pharmaceutical, biotechnology, and medical-device sectors; and manages company-wide Site Licenses for PharmaLive.com, Med Ad News, and R&D Directions.
 
 
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Contact:
Sandra Baker
215-944-9836